BD FACS¿ LYSE WASH ASSISTANT
Received Apr 22, 2025 · Event occurred Apr 7, 2025
Report 3027394506-2025-00018 · MDR key 21881859
Device
Generic name
Station, Pipetting Diluting Clinical Use
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
337146
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/ MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN- GO TO QUESTION #2.: CARRYOVER BETWEEN PATIENT SAMPLES.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. ANNEX G: G04034 - CONNECTOR/COUPLER. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE ISSUE 'CROSS CONTAMINATION' WAS CONFIRMED, THE CAUSE OF THE COMPLAINT WAS A CLOGGED RESTRICTOR. THE CUSTOMER REPORTED CROSS CONTAMINATION ON THEIR INSTRUMENT AND A FIELD SERVICE ENGINEER (FSE) WAS SENT ONSITE TO OBSERVE THE ISSUE. THE (FSE) CONFIRMED THAT THE CELL WASH PIPETTE WAS NOT BEING FLUSHED BETWEEN EACH TUBE AND REPLACED THE RESTRICTOR. THE FSE THEN TESTED THE INSTRUMENT AND CONFIRMED THAT IT WAS FUNCTIONING PER BD SPECIFICATIONS. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS. 4 COMPLAINTS REGARDING SIMILAR ISSUES REGARDING CLOGS RESULTING IN CARRYOVER WERE IDENTIFIED WITHIN 12 MONTHS OF THIS EVENT. DEVICE HISTORY REVIEW (DHR) REVIEW WAS NOT REQUIRED AS THE ROOT CAUSE WAS IDENTIFIED IN THE FIELD.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/ MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN- GO TO QUESTION #2.: CARRYOVER BETWEEN PATIENT SAMPLES.